Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Y015101 | — |
HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC.; HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC.; Information has been received from Business Partner/CRO on 19-Feb-2025. This spontaneous report was received from a/an Other health professional and refers to a(n) 12-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-Feb-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Solution for injection (lot #Y015101, expiration date: 06-Sep-2026), dose number 1, (1st dose),. On 19-Feb-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), Solution for injection (1st dose), (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), for the treatment of prophylaxis. On 19-Feb-2025, the patient experienced HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC.. On 19-Feb-2025, the patient experienced HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC.. At the reporting time, the outcome of HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC. and HCP called to report T/E for VARIVAX (case#02756055). VARIVAX was administered to 1 patient on 2/19/2025 to a 12 month old patient. Permission given to contact HCP. No other information was known or provided by HCP. No additional AE reported. No PQC. was unknown. The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable.
Sterile diluent solution for injection